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Phase 2 Study to Assess the Safety, PK, and PD of Sonefpeglutide (HM15912) in SBS-IF Subjects
Sponsor: Hanmi Pharmaceutical Company Limited
Summary
This is a randomized, double-blind, placebo-controlled, proof-of-concept (PoC), Phase 2 study to assess the safety, PK, and PD of SC administration of HM15912(sonefpeglutide) in adult subjects with SBS-associated intestinal failure (SBS-IF).
Official title: A Multicenter, Proof-of-concept, Phase 2 Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of HM15912 (Sonefpeglutide) in Adult Subjects With Short Bowel Syndrome-associated Intestinal Failure (SBS-IF)
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
18
Start Date
2022-03-03
Completion Date
2028-05
Last Updated
2025-12-11
Healthy Volunteers
No
Conditions
Interventions
HM15912 Active
Randomized, double-blind, placebo-controlled
Placebo
Randomized, double-blind, placebo-controlled
Locations (13)
Brigham & Women's Hospital
Boston, Massachusetts, United States
The Cleveland Clinic Foundation
Cleveland, Ohio, United States
UZ Leuven
Leuven, Vlaams Brabant, Belgium
Rigshospitalet Department of Digestive Diseases, Transplantation and General Surgery Section for Intestinal Failure
Copenhagen, Denmark
Hopital Beaujon
Clichy, Clichy, France
Centre Hospitalier Universitaire de Bordeaux
Bordeaux, France
Les Hospices Civils de Lyon
Lyon, France
Centre Hospitalier Universitaire de Nice
Nice, France
Asklepios Klinik St. Georg
Hamburg, Hamburg, Germany
Universitätsklinikum Tübingen
Tübingen, Tübingen, Germany
Wojewodzki Specjalistyczny Szpital im. Mikołaja Pirogowa w Łodzi
Lodz, Łódź Voivodeship, Poland
Samsung Medical Center
Seoul, South Korea
Central Middlesex Hospital
London, United Kingdom